BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUPAC VENTIPAC WITH ALARMS

    MDR report key: 978227 · Received January 15, 2008

    Report

    Report Number
    2182466-2008-00001
    Event Type
    Injury
    Date Received
    January 15, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 14, 2008
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    CBK
    PMA / PMN Number
    K030803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH MEDICAL, INC IMPORTS THE VENTILATOR FROM SMITHS MEDICAL INTERNATIONAL. SMITHS MEDICAL PM, INC KITS A PT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC IS REPORTING AS THE MANUFACTURER. PER PHONE CONVERSATION WITH MRI TECHNICIAN, THE FOLLOWING INFO REGARDING THE INCIDENT WAS OBTAINED: VENTILATOR STOPPED CYCLING ON A PARTIALLY BREATHING PT AND STARTED TO WHINE. PT WAS IN MRI WHEN THE VENTILATOR STOPPED CYCLING. PT REMAINED ON VENTILATOR UNTIL PROCEDURE WAS COMPLETED. PT COMPLAINED OF TROUBLE BREATHING AND WAS BAGGED. NO HARM TO THE PT. HE REPRODUCED THE FAILURE. HE LEFT THE VENTILATOR RUNNING WITH A TEST LUNG. HE DISCONNECTED THE TEST LUNG AND STARTED TO BREATH THROUGH THE CIRCUIT WITH A FAIRLY LARGE END TIDAL VOLUME. HE THEN SET THE CIRCUIT DOWN (STATIC CONDITION) AND CHECKED HOW LONG IT WOULD TAKE TO AUTO-CYCLE. A FAINT WHINING NOISE WAS HEARD AND IT TOOK 2 MINS AND 10 SECS BEFORE IT CYCLED. THE UNIT IS IN ROUTE TO SMITHS MEDICAL, INC FOR EVALUATION.

    Description of Event or Problem · 1

    USER FACILITY ALLEGED THAT, THE VENTILATOR STOPPED CYCLING ON A PARTIALLY BREATHING PT WHILE IN AN MRI. THE VENTILATOR INTERMITTENTLY DIDN'T CYCLE AND HAD A "WHINE" WHEN IT DIDN'T CYCLE. THE VENTILATOR REMAINED ON THE PT UNTIL THE PROCEDURE WAS COMPLETED. NO CLINICAL INTERVENTION WAS PERFORMED DURING THE PROCEDURE. AFTER THE PROCEDURE, THE PT COMPLAINED THAT SHE HAD A HARD TIME BREATHING, SO THE PT WAS TAKEN OFF OF THE VENTILATOR AND BAGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC VENTIPAC WITH ALARMS EMERGENCY VENTILATOR CBK SMITHS MEDICAL PM, INC. V200D

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention